CA2968954C - Compositions contenant des produits biopharmaceutiques inactives mais therapeutiquement actifs, stables a temperature ambiante et procedes de formulation associes - Google Patents

Compositions contenant des produits biopharmaceutiques inactives mais therapeutiquement actifs, stables a temperature ambiante et procedes de formulation associes Download PDF

Info

Publication number
CA2968954C
CA2968954C CA2968954A CA2968954A CA2968954C CA 2968954 C CA2968954 C CA 2968954C CA 2968954 A CA2968954 A CA 2968954A CA 2968954 A CA2968954 A CA 2968954A CA 2968954 C CA2968954 C CA 2968954C
Authority
CA
Canada
Prior art keywords
biopharmaceuticals
composition
carbohydrate
vaccine
dry
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CA2968954A
Other languages
English (en)
Other versions
CA2968954A1 (fr
Inventor
Victor Bronshtein
Original Assignee
Universal Stabilization Technologies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Universal Stabilization Technologies Inc filed Critical Universal Stabilization Technologies Inc
Publication of CA2968954A1 publication Critical patent/CA2968954A1/fr
Application granted granted Critical
Publication of CA2968954C publication Critical patent/CA2968954C/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/205—Rhabdoviridae, e.g. rabies virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/07—Bacillus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5252—Virus inactivated (killed)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5254—Virus avirulent or attenuated
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/20011—Rhabdoviridae
    • C12N2760/20111—Lyssavirus, e.g. rabies virus
    • C12N2760/20134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/20011—Rhabdoviridae
    • C12N2760/20111—Lyssavirus, e.g. rabies virus
    • C12N2760/20161—Methods of inactivation or attenuation

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Microbiology (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Mycology (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Biotechnology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne des compositions contenant des produits biopharmaceutiques inactivés mais thérapeutiquement actifs et des procédés de formulation associés. Les produits biopharmaceutiques sont encapsulés et immobilisés dans un hydrate de carbone vitreux sec, et irradiés pour être inactivés alors qu'ils se trouvent à l'état sec. Les compositions obtenues fournissent des produits biopharmaceutiques thérapeutiquement actifs mais inactivés stables à température ambiante, destinés à être utilisés dans des vaccins et autres applications.
CA2968954A 2014-09-26 2015-09-28 Compositions contenant des produits biopharmaceutiques inactives mais therapeutiquement actifs, stables a temperature ambiante et procedes de formulation associes Active CA2968954C (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201462056415P 2014-09-26 2014-09-26
US62/056,415 2014-09-26
US14/665,107 2015-03-23
US14/665,107 US9744227B2 (en) 2004-06-02 2015-03-23 Compositions containing ambient-temperature stable, inactivated but therapeutically active biopharmaceuticals and methods for formulation thereof
PCT/US2015/052710 WO2016049651A1 (fr) 2014-09-26 2015-09-28 Compositions contenant des produits biopharmaceutiques inactivés mais thérapeutiquement actifs, stables à température ambiante et procédés de formulation associés

Publications (2)

Publication Number Publication Date
CA2968954A1 CA2968954A1 (fr) 2016-03-31
CA2968954C true CA2968954C (fr) 2019-11-26

Family

ID=55582166

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2968954A Active CA2968954C (fr) 2014-09-26 2015-09-28 Compositions contenant des produits biopharmaceutiques inactives mais therapeutiquement actifs, stables a temperature ambiante et procedes de formulation associes

Country Status (5)

Country Link
US (2) US9744227B2 (fr)
EP (1) EP3197498B1 (fr)
AU (1) AU2015319819B2 (fr)
CA (1) CA2968954C (fr)
WO (1) WO2016049651A1 (fr)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9744227B2 (en) * 2004-06-02 2017-08-29 Universal Stabilization Technologies, Inc. Compositions containing ambient-temperature stable, inactivated but therapeutically active biopharmaceuticals and methods for formulation thereof
US20130309273A1 (en) 2012-05-17 2013-11-21 Kimberly Hassett Thermostable Vaccine Compositions and Methods of Preparing Same
US12447127B2 (en) 2011-05-17 2025-10-21 The Regents Of The University Of Colorado, A Body Corporate Thermostable vaccine compositions and methods of preparing the same
CN105579059B (zh) 2013-09-03 2020-07-31 佐治亚科技研究公司 热稳定的疫苗配制物、工艺和包含疫苗配制物的微针
US11273127B2 (en) 2014-05-06 2022-03-15 The Regents Of The University Of Colorado, A Body Corporate Compositions, methods and uses for thermally stable multi-targeted antigens
US10751408B2 (en) 2016-02-23 2020-08-25 The Regents Of The University Of Colorado, A Body Corporate Compositions and methods for making and using thermostable immunogenic formulations with increased compatibility of use as vaccines against one or more pathogens
WO2018201154A1 (fr) * 2017-04-28 2018-11-01 Universal Stabilization Technologies, Inc. Vaccins antipoliomyélitiques thermostables antigéniques et procédés associés
CN113395980B (zh) 2019-01-08 2023-09-15 韩国原子力研究院 利用放射线制备减毒活疫苗的方法及通过其制备的减毒活疫苗组合物
US20240229007A1 (en) * 2020-05-06 2024-07-11 Universal Stabilization Technologies, Inc. Inactivated vaccines & nucleic acid aptamer therapeutics derived therefrom
US20250177534A1 (en) * 2022-02-24 2025-06-05 Universal Stabilization Technologies Inc. Thermostable uv inactivated vaccines and other biopharmaceuticals

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4520574A (en) * 1983-02-25 1985-06-04 House Food Industrial Co., Ltd. Process for drying foods under reduced pressure
US5766520A (en) 1996-07-15 1998-06-16 Universal Preservation Technologies, Inc. Preservation by foam formation
WO2001037804A2 (fr) * 1999-11-22 2001-05-31 Universal Preservation Technologies, Inc. Conservation et preparation de matieres bioactives destinees au stockage et a l'administration dans des excipients hydrophobes
US6682695B2 (en) * 2001-03-23 2004-01-27 Clearant, Inc. Methods for sterilizing biological materials by multiple rates
EP1494651A4 (fr) * 2002-04-11 2010-10-13 Medimmune Vaccines Inc Conservation de matieres bio-actives au moyen de mousse lyophilisee
US20100120014A1 (en) * 2002-06-18 2010-05-13 Victor Bronshtein Stability Drying
US9744227B2 (en) * 2004-06-02 2017-08-29 Universal Stabilization Technologies, Inc. Compositions containing ambient-temperature stable, inactivated but therapeutically active biopharmaceuticals and methods for formulation thereof
US9469835B2 (en) * 2004-06-02 2016-10-18 Victor Bronshtein Preservation by vaporization
US8223918B2 (en) * 2006-11-21 2012-07-17 Varian Medical Systems, Inc. Radiation scanning and disabling of hazardous targets in containers
US20130122045A1 (en) * 2010-04-28 2013-05-16 Gamma Vaccines Pty Limited Cross-Protective Influenza Vaccine
US20130261372A1 (en) * 2012-03-30 2013-10-03 Elwha LLC, a limited liability company of the State of Delaware Device, System, and Method for Delivery of Sugar Glass Stabilized Compositions
WO2014155297A2 (fr) 2013-03-28 2014-10-02 Kapre Subhash V Systemes et procedes pour l'inactivation virale de compositions de vaccin par traitement par des glucides et un rayonnement

Also Published As

Publication number Publication date
US20180125966A1 (en) 2018-05-10
US20170087243A9 (en) 2017-03-30
WO2016049651A1 (fr) 2016-03-31
EP3197498A4 (fr) 2017-11-15
US10632188B2 (en) 2020-04-28
EP3197498B1 (fr) 2025-06-25
US9744227B2 (en) 2017-08-29
AU2015319819B2 (en) 2021-01-21
US20160089430A1 (en) 2016-03-31
AU2015319819A1 (en) 2017-04-20
EP3197498A1 (fr) 2017-08-02
EP3197498C0 (fr) 2025-06-25
CA2968954A1 (fr) 2016-03-31

Similar Documents

Publication Publication Date Title
CA2968954C (fr) Compositions contenant des produits biopharmaceutiques inactives mais therapeutiquement actifs, stables a temperature ambiante et procedes de formulation associes
RU2695523C2 (ru) Вакцины против вирусов свиней, стабильные в жидкой форме
MX2007011032A (es) Estabilizador quimicamente definido.
US11040015B2 (en) Method of long-term preservation of chemical and biological species using sugar glasses
CN105233296B (zh) 用于鸭病毒性肝炎活疫苗的耐热冻干保护剂及其制备方法和应用
Smith et al. Rabies vaccine preserved by vaporization is thermostable and immunogenic
CN105688202A (zh) 一种乙型脑炎疫苗组合物及其制备方法
Asim et al. Production of homologous live attenuated cell culture vaccine for the control of Peste des Petits Ruminants in small ruminants.
RU2603003C1 (ru) Вакцина инактивированная сорбированная против ящура типов а, о, азия-1
CN101474410A (zh) 一种动物用活疫苗耐热冻干保护剂及其制备方法
Latif et al. Effect of Stabilizers on Infectivity Titer of Freeze Dried Peste Des Petits Ruminants Virus Vaccine.
RU2259214C1 (ru) Способ получения вакцины оспенной инактивированной сухой "оспавир"
TWI580786B (zh) Vaccine of avian VII genotype new disease and its preparation method
Kumar et al. Whole-cell vaccine preparation: Options and perspectives
Frazatti-Gallina Purified Vero-cell rabies vaccine
Moges et al. Veterinary Vaccines: Unlocking the Power of Immunization for Livestock Health—A Review
THERMO-TOLERANT STABILITY AND IMMUNE RESPONSES OF A NEWLY FORMULATED THERMO-TOLERANT PESTE DES PETITS RUMINANTS VIRUS VACCINE
Yohannes et al. Veterinary Vaccines Handling, Transportation and Storage: Factors Challenging their Efficacy and Their Adverse Effects to the Host
US11213579B2 (en) Vaccines with enhanced immunogenicity, low allergenicity and reactogenicity
Mohamed et al. Shelf Life of Freeze-dried Foot and Mouth Disease Virus Stock Seeds
Haji Characterization of Antigenic Properties of a Selected Gram-Positive and Gram-Negative Bacteria Following Inactivation by Low-Energy Electron Beam Irradiation (LEEI)
SHENDY et al. PREPARATION OF A THERMOSTABLE BOVINE EPHEMERAL FEVER VIRUS VACCINE INACTIVATED ON THE TIME OF USE
EL-SERGANY et al. EFFICACY OF FREEZE-DRIED INACTIVATED VACCINE AGAINST RABBIT ENTEROTOXAEMIA
Shivanandappa et al. WE WILL OVERCOME COVID 19 TOO…
Thalen The next generation of biologicals and their production systems

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20170612

MPN Maintenance fee for patent paid

Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 9TH ANNIV.) - STANDARD

Year of fee payment: 9

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20240917

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20241001

MPN Maintenance fee for patent paid

Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 10TH ANNIV.) - STANDARD

Year of fee payment: 10

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250916

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250916